Study of Medication Patch to Treat Children Ages 6-12 With ADHD - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00586157

Purpose

The purpose of this study is to investigate the effectiveness of a medication skin patch called Methylphenidate Transdermal System (MTS). We will compare the MTS medicated patch to a placebo patch. We want to find out how well it treats ADHD during the early morning hours before a child leaves for school or summertime routines.

Condition	Intervention	Phase
ADHD Attention Deficit Hyperactivity Disorder	Drug: Methylphenidate Transdermal System Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety/Tolerability of Methylphenidate Transdermal System (MTS) for Before-School Dysfunction in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, Over the Course of the Day. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).
Efficacy Defined as Change From Baseline on the Investigator Rated DSM-IV Based ADHD Rating Scale, During the AM. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
Units on a scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. The possible range of scores for the scale is 0 (least severe) to 54 (most severe).

Secondary Outcome Measures:

Efficacy Defined as Change From Baseline on Investigator and Parental/Self-report Based Rating Scales and Questionnaires [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
The questionnaire includes two a sections, a clinician rated 20-item scale and a 14-item self-report section completed collaboratively by child and parent/guardian.

Units on the clinician rated scale range from 0-3 on a scale of severity, with 0 being the least severe item score and 3 being the most severe. Units on the self-report section ranged from 0-2 on a scale of severity, with 0 being the least severe item score and 2 being the most severe. The possible range of scores for the questionnaire is 88

Enrollment:	36
Study Start Date:	September 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Methylphenidate Transdermal System (MTS)	Drug: Methylphenidate Transdermal System Medication skin patch titrated to 20mg (at 10 mg and 20 mg doses) Other Name: Daytrana
Placebo Comparator: Placebo	Drug: Placebo Placebo skin patch titrated to 20mg (at 10 mg and 20 mg doses) Other Name: Placebo

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female outpatients 6 to 12 years of age.
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
Participation in structured morning routine (e.g. school, camp, or other organized activities).

Exclusion Criteria:

Mental retardation (IQ <75).
Subjects with a medical condition, or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
Subjects with moderate to severe dermatological atopy.
Subjects with known structural cardiac abnormalities.
Organic brain disorders.
Seizure Disorder.
Subjects with Tourette's syndrome, or a history of psychosis or bipolar disorder.
Subjects with current comorbid psychopathology that in the investigator's opinion will warrant immediate treatment or will interfere with the safe execution of the protocol (i.e. Anxiety or Major Depressive Disorder rated as moderate on CGI).
Subjects with a history of intolerable adverse effects or non-response to methylphenidate.
Pregnant or nursing females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586157

Locations

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Timothy Wilens, MD

Massachusetts General Hospital

More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wilens TE, Hammerness P, Martelon M, Brodziak K, Utzinger L, Wong P. A controlled trial of the methylphenidate transdermal system on before-school functioning in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 May;71(5):548-56.

Responsible Party:	Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00586157 History of Changes
Other Study ID Numbers:	2006-P-001633
Study First Received:	December 21, 2007
Results First Received:	November 22, 2010
Last Updated:	April 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

ADHD
Attention Deficit Hyperactivity Disorder
Daytrana
MTS Patch
Methylphenidate Transdermal System

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2012